Oral fluid collection device

Abstract

According to a first aspect of the present invention there is provided an oral fluid collection device. The oral fluid collection device comprises a handle, a swab holder, and a swab. The swab is in the form of a hollow tube of absorbent material coaxially located about the swab holder, such that the swab is supported by the swab holder along the entire length of the swab.

The invention claimed is: 
     
       1. An oral fluid collection device comprising:
 a handle; 
 a swab holder connected to the handle; 
 a swab in the form of a hollow tube of absorbent material coaxially located about the swab holder, such that the swab is supported by the swab holder along the entire length of the swab; and 
 a wick within the swab holder and being in fluid communication with the swab, the wick containing a soluble dye for the purpose of providing a fluid adequacy indication during use; 
 wherein the swab holder has an at least partially hollow core accommodating said wick, wherein the swab holder further comprises a wall parallel to the longitudinal axis of the swab holder and the longitudinal axis of the swab; wherein the swab holder further comprises an opening passing through the wall of the swab holder into the hollow core in a direction perpendicular to the longitudinal axis of the swab holder and the longitudinal axis of the swab, and a projection on an inner surface of the at least partially hollow core opposite the opening and which is configured to press the wick through the opening and into contact with the swab. 
 
     
     
       2. The device as claimed in  claim 1 , wherein the projection is a ramp inclined to press the wick through the opening and into contact with the swab. 
     
     
       3. The device as claimed in  claim 1 , wherein said swab holder and said handle are formed as two separate parts. 
     
     
       4. A device as claimed in  claim 1 , wherein the handle is transparent at least in the region of an end of the wick and the swab holder is opaque, and the swab holder obscures a portion of the wick coated or impregnated with said soluble dye. 
     
     
       5. A device as claimed in  claim 1 , wherein the swab holder is provided with one of a plug or a socket and the handle is provided with the other of a plug or a socket, the swab holder and the handle being connected by means of a mechanical fit formed between the plug and the socket. 
     
     
       6. An oral fluid collection device comprising:
 a handle; 
 a swab holder connected to the handle; 
 a swab in the form of a hollow tube of absorbent material coaxially located about the swab holder, such that the swab is supported by the swab holder along the entire length of the swab; and 
 a wick within the swab holder and being in fluid communication with the swab, the wick containing a soluble dye for the purpose of providing a fluid adequacy indication during use; wherein the swab holder further comprises a wall parallel to the longitudinal axis of the swab holder and the longitudinal axis of the swab; 
 wherein the swab holder has an at least partially hollow core, and a capillary passing through the wall of the swab holder into the at least partially hollow core which is configured to carry fluid between the swab and the wick. 
 
     
     
       7. The device as claimed in  claim 6 , wherein said swab holder and said handle are formed as two separate parts, and configured to be connected together in use. 
     
     
       8. The device as claimed in  claim 7 , wherein the handle is substantially transparent at least in the region of an end of the wick and swab holder is opaque. 
     
     
       9. The device as claimed in  claim 8 , wherein the swab holder obscures a portion of the wick coated or impregnated with said soluble dye. 
     
     
       10. A device as claimed in  claim 9 , wherein the swab holder is provided with one of a plug or socket and the handle is provided with the other of a plug or a socket, the swab holder and the handle being connected by means of a mechanical fit formed between the plug and the socket. 
     
     
       11. A method of manufacturing an oral fluid collection device, the method comprising:
 locating a swab in the form of a hollow tube of absorbent material about a swab holder, such that the swab is supported by the swab holder along the entire length of the swab; 
 either before or after locating the swab, inserting a wick into a passage within the swab holder such that at one end the wick extends out of an open end of said passage and at the other end, a projection on an inner surface of the passage within the swab holder guides the wick through an opening in the swab holder and into contact with said swab, the wick being at least partially coated or impregnated with a dye; and 
 connecting the swab holder to a handle. 
 
     
     
       12. The method as claimed in  claim 11 , wherein the swab is attached to the swab holder using one of:
 a mechanical fit; or 
 a plastic welding process such as laser or ultrasonic or microwave welding. 
 
     
     
       13. The method as claimed in  claim 11 , wherein the swab holder is connected to the handle using one of:
 a mechanical fit; or 
 a plastic welding process such as laser or ultrasonic or microwave welding. 
 
     
     
       14. The method as claimed in  claim 13 , wherein the swab holder is connected to the handle using a mechanical fit, the mechanical fit being achieved by the insertion of a plug formed with one of the swab holder or the handle being inserted into a socket formed with the other of the swab holder or the handle. 
     
     
       15. A testing kit comprising:
 an oral fluid collection device comprising a swab, a swab holder, and a handle; 
 a container arranged to receive the oral fluid collection device; 
 the swab in the form of a hollow tube of absorbent material coaxially located about the swab holder, such that the swab is supported by the swab holder along the entire length of the swab; 
 a wick within the swab holder and being in fluid communication with the swab, the wick containing a soluble dye for the purpose of providing a fluid adequacy indication during use, 
 wherein the swab holder has an at least partially hollow core accommodating said wick, wherein the swab holder further comprises a wall parallel to the longitudinal axis of the swab holder and the longitudinal axis of the swab; wherein the swab holder further comprises an opening passing through the wall of the swab holder into the at least partially hollow core, and a projection on an inner surface of the at least partially hollow core opposite the opening in a direction perpendicular to the longitudinal axis of the swab holder and the longitudinal axis of the swab, wherein the projection is configured to press the wick through the opening and into contact with the swab; and 
 the handle of the oral fluid collection device being arranged to cooperate with an inner surface of the container to retain the oral fluid collection device within the container. 
 
     
     
       16. The testing kit as claimed in  claim 15 , the oral fluid collection device being arranged to form a snap fit with the inner surface of the container when the oral fluid collection device is inserted into the container. 
     
     
       17. The testing kit as claimed in  claim 15 , the oral fluid collection device being arranged to form an interference fit with the inner surface of the container when the oral fluid collection device is inserted into the container. 
     
     
       18. The testing kit of  claim 15 , wherein the container contains a buffer solution.